Topcon Healthcare Solutions (THS), headquartered in Oakland, NJ, is a leading software engineering company of the eye care industry. THS is responsible for R&D, engineering, marketing, sales, and support of software solutions to the global market.
Topcon's mission is to make the impossible possible, by constantly innovating optical, imaging, and measurement technologies and developing new and advanced image management and networking solutions. Our goal is simple: to provide the ophthalmic medical community with the most innovative and indispensable software solutions so that doctors and researchers can better serve patients, ultimately improving outcomes in eye and vision care. THS is newly established in 2017 to provide the most advanced software solutions to the global market. We focus on IoT, Cloud and AI technologies to enable “Healthcare through the eye”.
Topcon Healthcare Solutions is a wholly owned subsidiary of Topcon Corporation of Tokyo, Japan.
Job Purpose: The Senior Systems Engineer leads systems engineering activities for complex electro-mechanical, software-controlled medical devices. The person should be experienced in developing design input requirements to meet customer needs and business objectives. This individual will also provide critical input to the systems architecture, system design specification, risk assessment, usability engineering, and own the systems integration and design change control process.
Core Job Duties:
• Translate customer needs, research findings, and business requirements into product requirements and specifications
• Develop system architecture, complete system design specification, and the electro-optical subsystem specifications
• Coordinates system engineering testing to verify systems functionality. Work with hardware and firmware engineers to debug systems and evaluate performance
• Lead development and maintenance of product specifications, requirements documents, risk and hazards analysis, design FMEA, usability, design V&V documentation, and other technical documentation
• Monitor and manage the efforts of third-party vendors and suppliers, define product or component specifications, qualification efforts, and development schedules
• Define usability evaluation plans and conduct and coordinate usability testing activities and ensure usability engineering is applied according to international standards
• Ensure system design and appropriate supporting documentation meets all safety and regulatory compliance
• Provides links between design inputs, architectural components and subsystem requirements, to ensure design meets technical and regulatory expectations
• Responsible for the system design and engineering change control process
• Provide technical leadership for product design, development, integration, testing, and reliability improvements
Education & Experience:
• Bachelor’s degree in Engineering and/or Science with 6+ years of experience in developing medical/diagnostics products. Master’s degrees preferred.
• Systems engineering experience (at least 2 years) in a highly regulated industry
• Familiarity with Zemax, Code V, or other optical design packages.
• Experience with rapid prototyping.
• Hands-on building and familiarity with general prototype principles and processes
• Experience in conceptualizing innovative and creative designs using strong analytical and problem-solving skills.
Knowledge, Skills, and Abilities:
• Knowledge of retinal imaging techniques such as fundus camera, autofluorescence, SLO, or OCT imaging is preferred.
• Strong understanding of optical and imaging systems
• Strong understanding of system, electrical, and mechanical design, as well as software integration.
• Strong programming skills, including C/C++, Matlab, Python and others
• Proven ability to solve problems independently and manage the workload of multiple projects and tasks
• Ability to effectively and clearly communicate technical concepts, ideas and knowledge to other individuals and teams.
• Working knowledge of ISO requirements, FDA regulations including Quality System Regulations, medical device design control, CE marking and product safety regulatory standards and manufacturing processes.
• Working knowledge of common laboratory test/inspection equipment is preferred.